UMIN-CTR Clinical Trial

Basic information
Public title	Feasibility study of photodynamic diagnosis using 5-aminolaevulinic acid during endoscopic submucosal dissection for early gastric cancer
Acronym	PDD using 5ALA for early gastric cancer
Scientific Title	Feasibility study of photodynamic diagnosis using 5-aminolaevulinic acid during endoscopic submucosal dissection for early gastric cancer
Scientific Title:Acronym	PDD using 5ALA for early gastric cancer
Region	Japan

Condition
Condition	Early gastric cancer
Classification by specialty	Gastroenterology Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	This study aimed to investigate the feasibility of photodynamic diagnosis using 5-aminolevulinic acid to identify gastric cancer during endoscopic submucosal dissection.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Diagnostic accuracy
Key secondary outcomes	Adverse events

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Medicine Device,equipment
Interventions/Control_1	Before endoscopic submucosal dissection, 20 mg/m2 of 5-aminolevulinic acid solution was given orally. After tumor resection, resected specimens were investigated by an endoscopic phododynamic diagnosis system, and red fluorescence-positive lesions were compared with the pathological result.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	85 years-old >=
Gender	Male and Female
Key inclusion criteria	1. An age of 20 years and over. 2. Histologically proven intestinal type gastric adenocarcinoma including papillary, well and moderate differentiated adenocarcinoma. 3. A performance status of 0-1 accord ing to the Eastern Cooperative Oncol ogy Group (ECOG) scale. 4. Adequate organ function including heart, lung, liver, kidney and bone marrow function in addition to clinical laboratory results. 5. Patients without synchronous or metachronous malignant disease, or multicentric cancer. 6. All patients gave written informed consent. 9. All patients gave written
Key exclusion criteria	1. Uncontrollable infectious disease including active tuberculosis. 2. Serious concurrent disease such as malignant hypertension, severe congestive heart failure, severe coronary ischemic disease, acute myocardial infarction, terminal liver cirrhosis, severe renal insufficiency, dialysis patients, uncontrollable diabetes mellitus, severe pulmonary fibrosis, interstitial pneumonia and so on. 3. Patients received bone marrow transplantation. 4. Patients with psychosomatic disorder. 5. Patients with porphyria or hypersensitivity to porphyrins allergy. 6. Women who are pregnant or hope to become pregnant during the study period. 7. Patients judged inappropriate for t he study by their physicians.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Tsutomu Namikawa Middle name Last name Tsutomu Namikawa
Organization	Kochi Medical School
Division name	Department of Surgery
Zip code	783-8505
Address	Kohasu, Oko-cho, Nankoku, Kochi 783-8505, Japan
TEL	+81-88-880-2370
Email	tsutomun@kochi-u.ac.jp

Public contact
Name of contact person	1st name Tsutomu Namikawa Middle name Last name Tsutomu Namikawa
Organization	Kochi Medical School
Division name	Department of Surgery
Zip code	783-8505
Address	Kohasu, Oko-cho, Nankoku, Kochi 783-8505, Japan
TEL	+81-88-880-2370
Homepage URL	http://www.kochi-ms.ac.jp/~fm_srgr1/index.html
Email	tsutomun@kochi-u.ac.jp

Sponsor
Institute	Kochi Medical School
Institute
Department

Funding Source
Organization	Japan Science and Technology Agency
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Department of Surgery, Kochi Medical School
Address	Kohasu, Oko-cho, Nankoku, Kochi
Tel	088-880-2370
Email	tsutomun@kochi-u.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 07 Month 07 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	2
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 06 Month 23 Day
Date of IRB	2017 Year 06 Month 22 Day
Anticipated trial start date	2017 Year 07 Month 07 Day
Last follow-up date	2021 Year 05 Month 05 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2017 Year 06 Month 29 Day
Last modified on	2021 Year 05 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032062